MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO FLAT MARKERS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSDV0016
Medical Device Problem Codes	Off-Label Use (1494); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a box of flat markers had been used beyond its expiration date.The customer kept them on their shelf and obtained restock from the office.It was noticed during the setup of an ukr procedure, that the devices had expired in february 2020.This is the sixth of eight boxes used.
Additional Manufacturer Narrative
The navio flat markers, part pfsdv0016 intended for use in treatment were not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed a contributing factor may be customer did not manage product expiration on shelf.No containment or corrective actions are recommended at this time.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO FLAT MARKERS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10228552
• Report Number: 3010266064-2020-01635
• Device Sequence Number: 3093589
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: PFSDV0016
• Device Catalogue Number: PFSDV0016
• Device Lot Number: 232106018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1